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Evaluating inclisiran for cholesterol management in heart disease

VictORION-INCLUSION: Evaluating INClisiran as a soLUtion to Improve LDL-C Management and cloSe Care Gaps in an Inclusive ASCVD and ASCVD Risk Equivalent populatiON

PHASE4 · Duke University · NCT06249165

This study is testing if a new cholesterol-lowering treatment called inclisiran can help people with heart disease manage their cholesterol better than just standard care alone.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment1440 (estimated)
Ages18 Years and up
SexAll
SponsorDuke University (other)
Locations39 sites (Birmingham, Alabama and 38 other locations)
Trial IDNCT06249165 on ClinicalTrials.gov

What this trial studies

VictORION-INCLUSION evaluates the effectiveness of inclisiran, a novel therapy, in managing cholesterol levels among patients with atherosclerotic cardiovascular disease (ASCVD). The trial consists of two parts: a randomized controlled trial comparing inclisiran plus usual care to usual care alone, and a single-arm trial where participants from the usual care group will start inclisiran after one year. The study aims to include historically underrepresented populations by utilizing electronic health records to identify eligible participants at high risk for ASCVD. Approximately 1440 participants will be enrolled to assess the impact of inclisiran on achieving LDL-C targets.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with established ASCVD or high ASCVD risk and elevated LDL-C levels despite statin therapy.

Not a fit: Patients who do not have ASCVD or elevated LDL-C levels, or those who are not on statin therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients struggling to manage their cholesterol levels despite existing therapies.

How similar studies have performed: Other studies have shown promise with similar approaches in managing cholesterol, but this specific evaluation of inclisiran in underrepresented populations is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria: Must meet all criteria below.

1. Males and females \>= 18 years of age
2. Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
3. Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy.
4. Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
5. On statin therapy, or have documented statin intolerance, as determined by the treating clinician.
6. From historically underrepresented populations in cardiovascular clinical research, including at least one of the following: female sex; Hispanic/Latino ethnicity; Black/African-American, Asian, or Native American race; rural dwelling based on the HRSA definition for determining rural grant eligibility.

Exclusion Criteria: Cannot meet any criteria below.

1. Planned use of other investigational products or devices during the course of the study.
2. Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening.
3. History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
6. New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \<25%.
7. Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or other methods (i.e. via ablation etc.) at the time of pre-screening.
8. Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.
9. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or alanine aminotransferase (ALT) elevation \>3x ULN, aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \>2x ULN (except participants with Gilbert's syndrome) at pre-screening confirmed by a repeat measurement at least one week apart.
10. End-stage renal disease (ESRD)

Where this trial is running

Birmingham, Alabama and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Atherosclerotic Cardiovascular Disease, Hyperlipidemia, Secondary Cardiovascular Prevention, Primary Prevention, Hypercholesterolemia, Lipid lowering therapies, Inclisiran

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.